Netherlands Quality of Life and Biomedical Cohort Studies_Head and Neck Cancer

In head and neck cancer (HNC), little is known about the long-term course of
quality of life (QoL) in patients and their informal caregivers, and its
determinants across the disease-span. New empirical evidence suggests that
tumour- and patient-related biomarkers, psychosocial functioning, and lifestyle
are also associated with QoL and survival. These associations can be influenced
by various cancer-related, personal, genetic, biological, psychobehavioural,
lifestyle-related, and social factors. Comprehensive insight in all these
factors assessed in a standardized manner is necessary to unravel these complex
associations.

The primary objective is 1) to describe the long-term course of QoL in HNC
patients and their informal caregivers and to identify cancer-related,
personal, genetic, biological, psychobehavioural, physical, lifestyle-related,
and social determinants of QoL.
Secondary objectives are: 2) To determine whether the association between QoL
and survival is direct or mediated by other variables, 3) To build predictive
models for QoL and survival, 4) To prospectively examine supportive care needs
in all phases of the disease, 5) To describe the long term course of QoL in
informal caregivers, 6) To establish a large QoL database and biobank of tissue
specimen, DNA, RNA, serum plasma and saliva, with integrated clinical
information.

NET-QUBIC_HNC is a multicenter prospective cohort study on HNC patients and
their informal caregivers.

There are no risks involved in this study for the participants (patients and
their caregivers). Participation burden involves the time investment to
complete the questionnaires and the measurements (physical tests, psychiatric
interview, psychological function, speech recording).
Participants can choose to fill out the questionnaires via pen / paper or
online. To reduce the burden for patients and their caregivers the measurements
will be done at home. When the participant prefers to visit the hospital for
the measurements, this is also an option. Traveling expenses will be covered.

To evaluate the feasibility and achievability of this cohort study we conducted
a pilot study. In this study we included 15 patients who completed the baseline
assessment. During the inclusion period (four months), 15 out of 26 (60%)
patients agreed to participate. Less women participated, 13% in responders
group versus 63% in non-responders group (p= 0.008). No other differences were
found between responders and non-responders. Responders completed more than 95%
of the questionnaires items, and rated the number of questions, time investment
and intimacy as feasible, and the physical and psychological burden as low.
In conclusion we can say that the comprehensive baseline assessment in patients
with HNC was considered feasible and participation rates were sufficient.